PDL BioPharma Product Sales Up 25 Percent On Cardene Growth
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm is focused on lifecycle management for Cardene as well as partnering opportunities for investigational drugs ularitide and Nuvion, CEO says.
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PDL BioPharma is focused on a comprehensive lifecycle management program for its top-selling product Cardene (nicardipine), which goes off patent in November 2009, CEO Mark McDade told analysts during the company's second-quarter earnings call Aug. 1. Overall net product sales for the Fremont, Calif., firm grew 25 percent year over year to $49 million, driven by revenues from Cardene, which recorded sales of $40.5 million in the second quarter of 2007, a 66 percent increase over the same period of 2006. Since PDL began marketing the acute hypertension treatment to U.S. hospitals in the second quarter of 2005, quarterly Cardene net sales have more than doubled, increasing from $16.7 million to $40.5 million in the second quarter of 2007, "confirming the terrific efforts of our hospital-based commercial sales and marketing organization," McDade said. The company's two-part strategy for extending the sales life of Cardene includes the "imminent" launch of a pediatric study, aimed at adding an additional six months of exclusivity to the calcium channel blocker's patent life, and launching new product formulations late in 2008, the exec said. PDL appears to have altered its stance somewhat on partnering its investigational acute decompensated heart failure medication ularitide and is now looking for a developmental partner. During the firm's year-end 2006 call, McDade said PDL was looking for a collaboration that offered access to another late-stage program for the hospital or acute care setting (1 (Also see "PDL BioPharma Seeks Ularitide Partner That Grants Rights To A Late-Stage Drug" - Pink Sheet, 22 Feb, 2007.)). Six months later, McDade noted during the second-quarter call that "we believe the scope of global heart failure drug development and commercialization is beyond our existing capabilities." "We are currently in very active corporate development discussions for ularitide and continue to target a partnership this year," McDade said. In July, the company launched RESTORE 2, a Phase III pivotal trial of Nuvion (visilizumab), PDL's investigational monoclonal antibody for treatment of IV steroid refractory ulcerative colitis, marking the second pivotal study for the program (2 (Also see "PDL Advances Ulcerative Colitis Treatment Nuvion Into Phase III" - Pink Sheet, 26 Apr, 2007.)). The company is looking to partner the mAb in indications outside of PDL's core focus in inflammatory bowel disease, McDade said. PDL is in the midst of a "rigorous portfolio review with external advisors" and plans to report the outcome at a research and development event in New York November 16, the exec said. Meanwhile, the firm is set to be fully operational in its new headquarters in Redwood City, Calif., during the fourth quarter, McDade said. - Shirley Haley ([email protected]) |